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CompletedPhase 4

Donepezil to Treat Dementia in Parkinson's Disease

Donepezil for Dementia in Parkinson's Disease: A Randomized, Double Blinded Placebo Controlled Crossover Trial

Asset

Donepezil

Listed sites

1

Recruiting sites

-

Enrollment

28

Study population

Lewy body dementia

Key I/E criterion

-

Primary endpoint

-

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary02-N-0115
Org study ID020115
NCT IDNCT00030979

Timeline

Milestones

Study start2002-02 (month precision)
Study first posted2002-02-18estimated
Study completion2005-03 (month precision)
Last update posted2008-03-04estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

Inclusion criteria

Age greater than or equal to 40.

A clinical diagnosis of Idiopathic PD, stages I-IV, using British Brain Bank Research Diagnostic Criteria.

Mild to moderate dementia with Mini Mental Status Score of 17-26

Exclusion criteria

The presence of an alternative cause of dementia such as AD or stroke, based on clinical evaluation. Subjects will have serologic screening for reversible causes of dementia, including syphilis, thyroid dysfunction and B12 deficiency.

Presence of uncontrolled hallucinations-hallucinations that are disruptive such that they would interfere with cognitive testing.

Anticholinergic or cholinergic therapy within 2 weeks prior to inclusion in the study except for Amantadine and Detrol.

Patients with unstable or clinically significant medical problems such as cardiac arrhythmia or unstable heart disease (e.g. new onset angina) that would, in the judgment of the investigators, interfere with the safe conduct of the study.

Patients enrolled in other protocols involving investigational drugs or surgery.

Severe depression: Geriatric Depression Scale score greater than or equal to 13.

Pregnancy or breast feeding.

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.